Several Regulatory Warning Letters, To Major Bio-Pharma Concerns, During March 2026. That’s News, Under Tangerine 2.0.

To be fair, Iovance, Novartis and BMS all received similar biological/pharmaceutical letter warnings, from FDA’s CBER.

The point of the spear then, is that even under Tangerine 2.0, the working parts of FDA (CBER) will expect major biopharma- to be careful — in what each claims, in its marketing materials. . . as to indications, and efficacy — each, not yet established by FDA vetted and approved studies.

[To my experienced eye, it would seem that the letter to Iovance makes the most serious allegations, by CBER.]

In any event, since we follow Gilead closely, here’s a bit of the FDA’s Kite / Gilead March 9 letter:

…The promotional materials make false or misleading claims and representations about the benefits of TECARTUS. Thus, the promotional materials misbrand TECARTUS within the meaning of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and make its distribution violative. 21 U.S.C. 321(n); 331(a); 352(a), (n). See 21 CFR 202.1(e)(5). These violations are particularly concerning from a public health perspective because the promotional materials make misleading representations about TECARTUS being more effective or having greater clinical benefit than has been demonstrated. This may cause doctors and patients to inaccurately weigh the risks versus benefits of treatment with TECARTUS, which can be fatal or life-threatening….

Now you know. Be careful out there, folks. Onward, grinning — on a perfectly sunny Spring afternoon in the steel and glass canyons.

नमस्ते